Our work and case studies

Challenge:

Accelerate first-in-human and Phase II trials for an oral dosage form intended for treatment of CNS disorders. A fully integrated approach was required, to include drug substance manufacture, formulation development, GMP clinical manufacture, IMP packaging, labelling and assembly, distribution, and compilation of a CMC dossier.

Customer:

Small biotech (Europe)

Outcome:

A fully integrated pharmaceutical development package, involving all disciplines to include API manufacture, formulation development, product manufacture, analytical method development/validation, QC/QA release, and CMC regulatory document compilation, was successfully delivered to satisfy aggressive timelines. Phase I and multi-centre Phase II studies were completed with confirmation of proof-of-concept, and ownership of the drug substance transferred to a large pharmaceutical company with continued support from Arcinova. 

API Manufacture, Formulation Development, Capsule Product Manufacture Case Study